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Feature: Pain points 

06-26-2019 16:44

Improving the treatment pathway for painful vertebral compression fractures

By Douglas P. Beall, MD  Summer 2019 (preview)

In a recent article published in the Journal of Bone and Mineral Research (JBMR), a taskforce commented that “the optimal management of vertebral fracture is uncertain.”1 This statement highlights the authors’ unfamiliarity with a salient publication from addressing that exact issue.2 The multispecialty panel that provided these consensus recommendations included experts who perform the procedures and used the RAND/UCLA Appropriateness Method to produce a clinical care pathway.

The RAND/UCLA Appropriateness Method is not new and was developed in the 1980s to determine and identify which care is over- or underutilized and to limit the amount of inappropriate care. This method has been further refined in North America and Europe and addresses the concept that, while randomized clinical trials are the “gold standard” for evidence-based medicine, they are generally either unavailable or cannot provide evidence at a level of detail necessary to make it applicable to patients seen in everyday clinical practice.

The methodology set forth by the authors, which formally answers the question of what to do with patients suffering from painful vertebral compression fractures, has been developed into a complete clinical care pathway (Fig. 1).2

VCF Clinical Care pathway

Fig. 1. Clinical care pathway for vertebral augmentation developed by a
multidisciplinary expert panel using the RAND/UCLA Appropriateness Method.

Treatment variables

The authors’ treatment recommendations are quite clear and highlight essential patient variables that had a prominent impact on the recommended treatment. According to the paper, nearly all variables (which were related to imaging finding and the patient presentation), “showed high statistical significance and their impact on vertebral augmentation was cumulative: the higher number of unfavorable factors the greater the weight of the decision to perform vertebral augmentation rather than nonsurgical management.”

Patient selection

The treatment recommendations were constructed only for patients with osteoporotic vertebral compression fractures (VCFs) who were in moderate to severe pain and who had corroborating evidence of a fracture via imaging results. The only absolute contraindications were active infection at the surgical site and an untreated bloodborne infection.

The multidisciplinary group found that vertebral augmentation was appropriate in patients with imaging findings of a fracture and with worsening symptoms and in patients with two to four unfavorable factors, which included:

  • Progression of height loss
  • Severe impact on functioning
  • More than 25% height loss
  • Presence of a kyphotic deformity

There were also key factors that determined the appropriateness of vertebral augmentation, including:

  1. Duration of pain
  2. Advance imaging finding
  3. Impact of the VCF on the patient’s daily functioning
  4. Degree of height reduction
  5. Kyphotic deformity
  6. Progression of height loss
  7. Evolution of the patient’s symptoms

It is worth noting that the duration of time since the fractures was not considered relevant to the treatment decision. The recommendations for this decision were to be based on the seven key factors above rather than on time.

The follow-up after vertebral augmentation was also addressed. The panel recommended a follow-up within 2 to 4 weeks after augmentation and recommended the patients’ underlying disorder of osteoporosis be addressed.

Conclusion

The recommendations produced by the experts were designed to support the management of a heterogeneous group of patients with painful osteoporotic VCFs and were designed to function at a high level of granularity. This level is functionally at the level of the patient, and the experts gave firm recommendations that are extremely favorable to vertebral augmentation and provides guidelines on how patients should be appropriately treated using real data and an established process.2 Wider public circulation of this knowledge may help ensure that these important treatment recommendations are appropriately considered by organizations constructing guidelines.

SIR participated in the development of these guidelines and affirms the value of the document in treating patients who have a higher relative risk of mortality with a treatment that has been shown to be life-saving and life prolonging.3 The society is also preparing to produce clinical practice guidelines to formalize treatment recommendations such as these—another way that SIR supports its members with helpful information that can augment their practice.

References

  1. Ebeling PR, Akesson K, Bauer DC, Buchbinder R, Eastell R, Fink HA, Giangregorio L, Guanabens N, Kado D, Kallmes D, Katzman W, Rodriguez A, Wermers R, Wilson HA, Bouxsein ML. The Efficacy and Safety of Vertebral Augmentation: A Second ASBMR Task Force Report. J Bone Miner Res. 2019 Jan;34(1):3-21. doi: 10.1002/jbmr.3653.
  2. Hirsch JA, Beall DP, Chambers MR, Andreshak TG, Brook AL, Bruel BM, Deen HG, Gerszten PC, Kreiner DS, Sansur CA, Tutton SM, van der Meer P, Stoevelaar HJ. Management of vertebral fragility fractures: A clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method. Spine J. 2018 Aug 7. pii: S1529-9430(18)31084-2. doi:10.1016/j.spinee.2018.07.025. [Epub ahead of print] PMID: 30096377
  3. Ong KL, Beall DP, Frohbergh M, Lau E, Hirsch JA. Reply to “At what price decreased mortality risk?” Osteoporos Int. 29(8), 1929&endash;1930. 2018 May 3., doi: 10.1007/s00198-018-4551-4.
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In early 2020, SIR and publishing partner Thieme Medical Publishers, Inc., will release a valuable new multidisciplinary resource on vertebral augmentation, edited by Douglas P. Beall, MD. We are pleased to print below the preface to this upcoming book.

Preface to The Comprehensive Guide to Vertebral Augmentation: Vertebroplasty, Kyphoplasty and Implant Based Augmentation

By Douglas P. Beall, MD

Vertebral augmentation has been one of my very favorite spine treatments since I performed my first case in 1994 and saw the incredibly good and immediate results. This was done under the aegis of Dr. John Mathis who published the last comprehensive work on Vertebral Augmentation in 2006. Thirteen years later we have seen significant advancements in techniques, literature contributions and augmentation devices and all of these topics are covered in this Guide.

What we know now about the treatment of vertebral compression fractures (VCFs) that we didn’t know a decade ago is that treating these fractures with augmentation is demonstrably life saving and life prolonging and is one of the very few things we do in medicine that attains this benchmark. To break it down to a personal level for those practitioners performing vertebral augmentation, the number of patients needed to treat (statistically called the NNT) to save one life at one year is only fifteen patients and, on the average, each treated patient will average between two and seven years of additional life expectancy.

In my own practice centered on the treatment of painful spine conditions, vertebral augmentation produces the best results of anything we do with an average pain score that decreased from a 9 out of 10 to a 1.4 at the first posttreatment visit in our patients that we enrolled in the largest post-market trial done to date. The transition of technologies from vertebroplasty to intravertebral implants has given new dimensions and has produced even significantly better improvements in pain as well as significantly greater anatomic restoration of anatomy and fewer subsequent fractures.

This book was designed to be a comprehensive guide and has certainly accomplished that discussing all aspects of vertebral augmentation including the history, techniques, approaches, troubleshooting, implant augmentation, pre-procedure and postprocedure assessments, osteoporosis treatment, fill material, augmentation outside of the spine and even a masters chapter where the very best and most experienced vertebral augmentation physicians share their tips and pearls. We have even included conditions and concepts never before described in the medical literature. It has been a pleasure and a privilege to be involved in the writing of this book. I would like to thank all of my editors and authors and all others who have made this work possible. From an amazing beginning of a transoral injection of bone cement into a painful benign tumor affecting the C2 vertebral body to today's incredible advancements, vertebral augmentation just keeps getting better and better.

Watch SIR communication channels for more details on this important resource!

   

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